HIGH

Elixir by Coco March Tinted Mineral Sunscreen SPF 50 Recalled for CGMP Deviations

A recall is active for Elixir by Coco March Tinted Mineral Sunscreen SPF 50 amid CGMP deviations. The product is distributed by CA Botana International, Inc. The recall cites CGMP deviations as the hazard and class II designation. Consumers should stop using the product and follow guidance from healthcare providers.

Quick Facts at a Glance

Recall Date
October 10, 2025
Hazard Level
HIGH
Brands
SUNSCREEN, CA-Botana International
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
5 states
At-Risk Groups
GENERAL

Hazard Information

CGMP Deviations

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact CA BOTANA International, Inc. or your healthcare provider for guidance. Notification method: Letter

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About This Product

Tinted mineral sunscreen for SPF 50 with 21% zinc oxide. Used for sun protection with tint for cosmetic coverage.

Why This Is Dangerous

CGMP deviations indicate potential quality control issues in manufacturing. The exact safety impact is not specified in the notice.

Industry Context

This recall is not described as part of a larger industry pattern in the provided data.

Real-World Impact

Consumers may face compromised product quality or inconsistent sunscreen protection. Immediate cessation of use is advised.

Practical Guidance

How to identify if yours is affected

  1. Examine bottle for Lot D53681
  2. Check expiration date 03/31/2027
  3. Verify NDC 35192-050-17 and UPC 6 7229 99913 8

Where to find product info

NDC and UPC printed on the bottle; Lot number on bottle; expiration date on cap or label

What timeline to expect

Refunds or replacements typically 4-8 weeks after claim processing

If the manufacturer is unresponsive

  • Document all communications
  • Escalate to consumer protection agencies if needed
  • Consider credit card dispute if policy allows

How to prevent similar issues

  • Check CGMP compliance when buying cosmetics/health products
  • Verify lot numbers during recalls
  • Prefer products with clear manufacturing information and reputable distributors

Documentation advice

Keep photos of bottle, lot, expiration, purchase receipt, and all recall communications

Product Details

Brand: SUNSCREEN; Actual brand variants: SUNSCREEN, CA-Botana International. Product: Elixir by Coco March Tinted Mineral Sunscreen SPF 50. Size: 2.1 oz (62 g) per bottle. NDC: 35192-050-17. UPC: 6 7229 99913 8. Lot: D53681. Expiration: 03/31/2027. Distribution: CA, CO, FL, PR, WA. Sold/distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. Recall date: 2025-10-10. Status: Active.

Reported Incidents

No injuries or incidents have been reported in the provided data.

Key Facts

  • 1) SPF 50 tinted mineral sunscreen
  • 2) 2.1 oz (62 g) bottles
  • 3) Lot D53681, exp 03/31/2027
  • 4) NDC 35192-050-17, UPC 6 7229 99913 8
  • 5) Distributed by VitaTienda Co U.S.A., San Juan, PR 00646

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
BURNOTHER

Product Details

Model Numbers
Lot D53681
exp 03/31/2027
UPC Codes
35192-050
35192-050-17
Affected States
CA, CO, FL, PR, WA
Report Date
December 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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